Reporting to the Global Patient Safety (GPS) TA Lead, the Director, GPS provides PV and RM expertise, leadership, and mentorship of team members within the TA matrix. You may also have direct management of relevant GPS personnel. Responsible for contributing to the management of, and have shared accountability for the safety profile with the TA. This includes results that support products within the assigned portfolio. This position requires ability to work with and influence colleagues in a matrix environment and with senior management. This is a key member of the GPS TA team. The Director has a major impact on drug development and commercialization decisions, strategies and operations, in all relevant territories globally.
In this role, a typical day might include the following:
With oversight from GPS TA Lead (Ex Dir of Sr Dir), responsible for all GPS activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc); review and contribute to clinical documents (Investigator Brochures, protocols, clinical study reports, etc) focusing input on safety sections. Lead cross-function Safety Monitoring Team activities.
Represent GPS for assigned compounds on cross-functional teams, including but not limited to Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron.
Proactively identify and develop plans/ strategies for non-compound specific Global Patient Safety activities. Resource for medical review of assigned compounds. Actively participate in the development and maintenance of relevant SOPs and working practices. Actively participates in continuous improvement activities within both the TA and the GPS organization
This role might be for you if:
- You have the ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Function as an SME internally and externally to GPS for assigned compounds.
- Have the ability to utilize PVRM safety database for purposes of medical case review and simple queries.
- Are able to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
- MD highly preferred.
We are seeking individuals with more than 4+ years total proven experience in GPS or equivalent including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with proven achievements in safety (ex. supporting an ISS; responsible for CSR content).